Model Number 2420-0007 |
Device Problems
False Alarm (1013); Stretched (1601); Obstruction of Flow (2423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics were not provided.
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Event Description
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It was reported that during mid infusion, they were doing a syringe push to the patient and had an alarm.There was no patient harm.
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Manufacturer Narrative
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Additional information added; h.6.(device code) no product will be returned per customer.The customer¿s report of syringe push to the patient and an alarm and causing a balloon in the silicone segment was confirmed per photo provided by the customer.Photo provided shows a bulge/balloon in the silicone segment tubing near the upper fitment.The root cause for the source of the excessive pressure is unknown.
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Event Description
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It was reported that during a mid-infusion, they were doing a syringe push to the patient and had an alarm.Picture provided by the customer shows a "bulging" in the silicone segment.It was further confirmed during follow up, that there was no patient harm as a result of this event.
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Search Alerts/Recalls
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